Updated to include comment from Stryker and to adjust “reprocessed” language to “re-sterilized”
Stryker‘s (NYSE:SYK) Sustainability Solutions biz said it recalled a select number of re-sterilized AngioDynamics (NSDQ:ANGO) Soft Vu omni flush angiographic catheters due to reports of tip separation.
AngioDynamics said it is not associated with the recall, and that the devices affected have their own FDA clearance and are “specifically Stryker Sustainability Solutions Products.”
The devices were “part of Stryker’s (formerly Ascent Healthcare Solutions) open-but-unused program, which was strictly a sterilization service for open-but-unused devices,” according to an email statement from Stryker.
“These devices have not been re-sterilized under Stryker’s open-but-unused program since 2008 and the program is no longer active at Sustainability Solutions,” Stryker wrote in an email statement. “These devices were not used clinically prior to sterilization and distribution by Ascent/Stryker. All single-use devices (SUDs) remanufactured and reprocessed by Stryker are not impacted by the recall and all activity has been completed by Sustainability Solutions in relation to this recall.”
The FDA labeled the recall as Class I. Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Soft-Vu omni flush angiographic catheter is used to inject contrast dye into blood vessels in preparation for cardiac angiograms through a small puncture, according to an FDA notice.
Stryker Sustainability Solutions said it received reports of separation of the tip of the catheter from the main body which can lead to loss of device function, the possible need for surgical intervention to retrieve separated segments and other complications, such as internal organ injury, stroke, kidney failure and intestinal failure.
The select recall affected 167 units distributed to Texas, Utah, Pennsylvania, California, Vermont, Maine, Washington, Virginia, New York, Maryland, and Connecticut, the company said. A total of 27 lot numbers are affected by the recall, manufactured between November 7, 2003 and October 18, 2008 and distributed between January 5, 2004 and December 3, 2008, according to an FDA posting.
Stryker said it has completed all actions related to the recall.
AngioDynamics released a statement today distancing itself from the recall, saying that “the Soft-Vu catheter line is intended and indicated for single use.”
“AngioDynamics believes this to be the safest use of its products. Stryker Sustainability Solutions has no connection to AngioDynamics and has neither sought nor been given any approval by AngioDynamics to reprocess AngioDynamics products,’ AngioDynamics wrote in a response to the recall.
